Field of Invention
The presently disclosed invention relates generally to medical device detection devices and more particularly to ultrasound devices with detection capability.
Description of Prior Art
A-mode ultrasound is the simplest mode of ultrasound pulse-echo technology having a single pulse-echo element that produces a one-dimensional data vector consisting of the amplitude of the ultrasonic echo sampled at regular time intervals since the time of the pulse.
An A-mode Echograph (also known as an echogram, or time-amplitude graph) is a Cartesian graph in which the horizontal axis represents the time (t) required for the return of the echo from an ultrasound pulse, and the vertical axis (a) represents the strength or amplitude of the echo at each value of t. The greater the reflection at the tissue interface, the larger the signal amplitude.
One of the earliest applications of A-mode Echographs in medical diagnostics was for the evaluation of breast tumors. Prior art breast cancer detection systems using A-mode ultrasound Echographs are well known. In these systems, the ultrasound echo waveforms of living intact breast tumors are displayed as Echographs on an analog oscilloscope.
Further, a quantitative index has been developed by prior art technology for breast tumor comparison, called the A-scan area ratio, also referred to as the A-mode area ratio, which was introduced for the purpose of classifying soft tissue abnormalities. The A-mode area ratio was originally calculated by comparing the area subtended under an analog A-mode time-amplitude Echograph to a base line area value and computing the ratio. If the A-mode area ratio ratio is greater than 1.0, the soft tissue abnormality is likely abnormal. If the ratio is less than 1.0, the soft tissue abnormality is likely non-abnormal. To summarize, an abnormal breast mass has greater echogenic density.
However, the A-mode type of diagnostic ultrasound has been long abandoned and replaced with B-mode ultrasound technology. Today the field of ultrasound diagnostics is clearly dominated by work on B-mode, C-mode, M-mode, Doppler mode, and others.
All prior art techniques however, suffer from inaccuracies because they use manual and/or analog methods that are not suitably accurate or reliable.
Therefore, what is needed is a method and apparatus for the classification and detection of palpable soft tissue masses, such as breast mass(es).
Prior art methods for classification of breast masses using A mode probes used an analog oscilloscope for its output and directly displayed raw echo wave forms which then need to be interpreted by trained personnel.
Further, in prior art techniques for classification of breast masses using A mode probes used human doctors to process the observed data, measure areas subtended by displayed analog waveforms, and draw an inference therefrom.
The inference method used by prior art for classification of breast masses is a manual calculation of the A mode area ratio method using visual inspection of the displayed analog ultrasound data. The accuracy of the prior art A mode area ratio method is flawed in the two following ways. First, it includes within the computed total area beneath the waveform that represents echoes from the breast skin where the probe is placed as well as including the area beneath the waveform that represents echoes from the breast mass itself. Second, the method of computation involves visual inspection and estimation of wave traces on a small screen oscilloscope with a limited amount of data available.
Additionally, the referenced prior art apparatus for the classification of breast masses using A-mode probes uses a custom analog A-mode ultrasound probe to acquire the observed data.
Prior art apparatus for the classification of breast masses using A-mode probes uses an analog oscilloscope for its output means, directly displaying raw echo wave forms which then needed to be interpreted by trained personnel.